MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0706-XTW

Device Problem Incomplete Coaptation (2507)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated, and the reported slda associated with the clip detaching from the posterior leaflet per the physician is related to poor tissue integrity and therefore related to patient conditions.Unspecified tissue injury and mitral valve insufficiency/regurgitation appear to be related to the slda.Tissue damage and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2024, a patient presented with grade 4 functional mitral regurgitation, posterior chord restriction, and unhealthy tissue for a mitraclip procedure.One mitraclip xtw (lot: 31016r1007) was implanted and the mr was reduced to grade 1.On (b)(6) 2024, the patient returned with a single leaflet device attachment (slda) and recurrent mr grade 1+.Per the physician, the slda was due to poor tissue integrity.Tissue damage was observed.A second clip intervention was performed to stabilize the slda.A ntw mitraclip (lot: 30607a1025) was implanted however, mr remained unchanged at grade 1+.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18748278
• MDR Text Key: 335933701
• Report Number: 2135147-2024-00785
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0706-XTW
• Device Lot Number: 31016R1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 111 KG